Flash Glucose Monitoring Targets in Gestational Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 205
- Locations
- 2
- Primary Endpoint
- Glycemic control
Study Overview
Brief Summary
The use of glucose monitoring sensors is already well-established in pregnant women with type 1 diabetes (T1D), where it has been proven to improve glycemic control and perinatal outcomes. However, it has not yet been sufficiently researched in the area of gestational diabetes (GDM). Some smaller studies have shown a favorable effect on glycemic control, but no statistically significant differences were observed in reducing perinatal complications. A randomized, prospective study will include 200 pregnant women with GDM, treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases at the University Medical Centre Ljubljana. Participants will be divided into two groups. The first group will measure subcutaneous glucose using FSL in addition to self-monitoring of blood glucose (SMBG) while fasting and 60 minutes after main meals at the same time intervals. In both groups, glycemic targets, maternal outcomes, and neonatal outcomes will be monitored. In the FSL + SMBG group, sensor parameters for glycemic control will also be tracked.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases for gestational diabetes (GDM),
- •Agreement with the study protocol and ability to follow the study protocol,
- •Diagnosis of GDM established using the standard recommended OGTT method between the 24th and 28th weeks of pregnancy,
- •Age between 18 and 40 years.
Exclusion Criteria
- •History of bariatric surgery,
- •Treatment with systemic corticosteroids for more than 14 days prior to inclusion in the study,
- •Multiple pregnancy,
- •Hospitalization for psychiatric illness within the last year,
- •First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.
Outcomes
Primary Outcomes
Glycemic control
Time Frame: Up to delivery
Average Fasting Glucose Concentration: Measured in mmol/L, calculated from fasting blood glucose readings and average Postprandial Glucose Concentration: Measured in mmol/L, based on glucose readings taken 60 minutes after main meals.
Secondary Outcomes
- Birth Weight(At birth of infant)
- Large-for-Gestational-Age (LGA) Infant(At birth of infant)
- Mean Glucose (MG) in FSL+ SMBG group(Up to delivery)
- Mean Amplitude of Glycemic Excursions (MAGE) (FSL+SMBG group)(Up to delivery)
- Time in Range - TIR (SMBG+FSL group)(Up to delivery)
- Adherence to the Intervention(Up to delivery)
- Gestational Weight Gain (GWG)(Up to delivery)
- Mode of Delivery(At delivery)
- Occurrence of Hypertensive Disorders(Up to delivery)
- Small-for-Gestational-Age (SGA) Infant(At birth of infant)
- Gestational Age at Birth(At birth of infant)
- Neonatal Hypoglycemia(At birth of infant)
- Pregnancy loss(<28 days of life)
- Hyperbilirubinemia(Within first 7 days of life)